Expired Study
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Orangeburg, New York 10962


Purpose:

This study will evaluate the effectiveness of a psychosocial treatment, Critical Time Intervention, in easing the transition from hospital to community in people with severe mental disorders.


Study summary:

Severe mental illness (SMI) encompasses a wide range of mental disorders and disabilities, but commonly includes disorders that involve symptoms of psychosis. Psychotic symptoms may involve hallucinations, a lost sense of reality, or other distressing symptoms. About 6% of people experiencing psychotic symptoms seek inpatient treatment at a psychiatric hospital. Hospital treatment for a person with SMI often focuses on rapid improvement of negative symptoms and promotion of the necessary skills to successfully return to the community after leaving the hospital. Despite preparation for community integration, the transition from hospital to community remains a difficult time for many people with SMIs, with those affected having an increased chance for suicide, homelessness, and relapse. Critical Time Intervention (CTI), a psychosocial treatment program that aims to restore skills for community living and to assist in seeking service and support in the community, may be more effective than usual care in preventing these adverse outcomes after hospital discharge. This study will compare the effectiveness of CTI versus usual services in preventing homelessness and other adverse outcomes after leaving a psychiatric hospital among people with SMI and psychosis. Participation in this study will last 18 months. Potential participants will undergo an initial 15- to 30-minute interview that will include questions about current mental, physical, and living conditions; history of psychiatric services; and alcohol and drug use. Eligible participants will then undergo the first full interview, which will include a full review of medical records and will last between 2 and 3 hours. After this interview, participants will be assigned randomly to receive CTI or usual services. For participants assigned to CTI, a CTI specialist will visit participants in the hospital and in their homes and will stay in contact with participants for 9 months after hospital discharge. During visits with the CTI specialist, participants will receive training in community living skills and help finding service and support in the community. Participants assigned to usual services will receive the usual care and community services offered to people recently leaving a psychiatric hospital. After leaving the hospital, participants in both groups will be asked to participate in 15 follow-up interviews, which will include repeat questions from the 2 initial interviews. Interviews will be conducted once every 6 weeks until 18 months after hospital discharge and will last between 60 and 90 minutes.


Criteria:

Inclusion Criteria: - Diagnosis of psychosis - Homelessness during the 18 months before study entry - English speaking


Study is Available At:


Original ID:

R01 MH059716,#4640R


NCT ID:

NCT00621465


Secondary ID:

R01MH059716


Study Acronym:


Brief Title:

Critical Time Intervention in the Transition From Hospital to Community in People With Severe Mental Illness


Official Title:

CTI in the Transition From Hospital to Community


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

59 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York State Psychiatric Institute


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel Herman, DSW
Principal Investigator
NYS Psychiatric Institute

Study Dates

Start Date:April 2002
Completion Date:October 2007
Completion Type:Actual
Primary Completion Date:October 2007
Primary Completion Type:Actual
Verification Date:December 2011
Last Changed Date:December 28, 2011
First Received Date:February 20, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of adverse outcomes after hospital discharge, particularly homelessness
Time Frame:Measured over 18 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Critical Time Intervention (CTI)
Description:CTI is designed specifically to enhance the continuity and focus of care during the transition from psychiatric hospital to community care. CTI does not replace community treatment and support, but instead is meant to complement available services. CTI will provide training in community living skills and in team-managed transfer of caregiving from hospitals to services and supports in the community. Participants will receive CTI for 9 months after hospital discharge.
Arm Name:2
Intervention Type:Behavioral
Name:Usual care
Description:Usual care will include the standard aftercare and community care services.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:2
Description:Participants will receive usual care and the Critical Time Intervention.
Study Arm Type:Active Comparator
Arm Name:1
Description:Participants will receive standard aftercare and community care services.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York State Psychiatric Institute
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Herman D, Conover S, Felix A, Nakagawa A, Mills D. Critical Time Intervention: an empirically supported model for preventing homelessness in high risk groups. J Prim Prev. 2007 Jul;28(3-4):295-312. Epub 2007 Jun 1.
PMID:17541827

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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